Land: Israel
Språk: engelska
Källa: Ministry of Health
BUDESONIDE
ASTRAZENECA (ISRAEL) LTD
R03BA02
POWDER FOR INHALATION
BUDESONIDE 200 MCG/DOSE
INHALATION
Required
ASTRA ZENECA AB., SWEDEN
BUDESONIDE
BUDESONIDE
Bronchial asthma.
2022-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only BUDICORT ® BUDICORT ® 100 mcg 200 mcg TURBUHALER ® TURBUHALER ® Powder for Inhalation Powder for Inhalation Composition: Each dose contains: Budesonide 100 mcg Budesonide 200 mcg FOR INACTIVE INGREDIENTS, PLEASE REFER TO SECTION 6 - "FURTHER INFORMATION". READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Treatment of bronchial asthma. THERAPEUTIC GROUP: Corticosteroid. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive to Budesonide or to any of the other ingredients contained in the medicine. SPECIAL WARNINGS REGARDING USE OF BUDICORT TURBUHALER: BEFORE TREATMENT WITH BUDICORT TURBUHALER TELL YOUR DOCTOR IF: • You have a lung infection. • You have a cold or chest infection or any problems with breathing. • You have or have ever had tuberculosis (TB). • You have liver function problems. If you experience blurred vision or other visual disturbances contact your doctor. DRUG INTERACTIONS IF YOU ARE TAKING, OR IF YOU RECENTLY TAKEN, OTHER MEDICINES INCLUDING NON- PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. Especially inform the doctor or pharmacist if you are taking: • Steroid medicines. • Medicines to treat fungal infections (such as itraconazole and ketoconazole). • Medicines to treat HIV (such as ritonavir or cobicistat-containing products). PREGNANCY, BREAST-FEEDING AND FERTILITY: • If you are pregnant, breast-feeding, may be pregnant or are planning pregnancy, consult your doctor before using Budicort Turbuhaler. Do not use Läs hela dokumentet
THIS CONTENT OF THIS LEAFLET HAS BEEN CHECKED AND APPROVED IN JANUARY 2012 AND UPDATED ACCORDING TO THE GUIDELINES OF THE MINISTRY OF HEALTH IN FEBRUARY 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Budicort ® Turbuhaler ® 100 micrograms / dose, inhalation powder Budicort® Turbuhaler® 200 micrograms / dose 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Budesonide 100 micrograms/actuation. Budesonide 200 micrograms/actuation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Breath-actuated metered dose powder inhaler. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Budicort is recommended in patients with bronchial asthma. 4.2 Posology and method of administration Posology The dosage of Budicort Turbuhaler is individual. Budicort Turbuhaler is for oral inhalation When transferring patients to Turbuhaler from other devices, treatment should be individualised, The drug and method of delivery should be considered. The dosage should be individualised. The dose should always be reduced to the minimum needed to maintain good asthma control. Adults (including elderly) and children over 12 years of age: When starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage in adults should be 200 - 1600 micrograms daily, divided into 2-4 administrations. In less severe cases and children over 12 years of age, 200 - 800 micrograms daily, in divided doses, may be used. During periods of severe asthma, the daily dosage can be increased to up to 1600 micrograms, in 2-4 divided doses. Children 6 years-12 years of age: 200 - 800 micrograms daily, in divided doses. During periods of severe asthma, the daily dose can be increased up to 800 micrograms. The maintenance dose should be the lowest possible. It is possible that the patient will not taste or perceive any medicine when Budicort Turbuhaler is used; this is because such a small amount of substance is dispensed. In patients where an increased therapeutic effec Läs hela dokumentet